ID

33108

Description

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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Versions (1)
  1. 11/28/18 11/28/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 28, 2018

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License

Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

English

Visit 1: Consent Form

1 forms  
  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Administrative data
Description

Administrative data

Date of Visit
Description

Date of Visit

Data type

date

Subject Number
Description

Subject Number

Data type

integer

Informed Consent
Description

Informed Consent

I certify that Informed Consent has been obtained prior to any study procedure.
Description

record the Informed Consent Date

Data type

date

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Visit 1: Consent Form

1 forms
  1. StudyEvent: ODM
    1. Visit 1: Consent Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Informed Consent
I certify that Informed Consent has been obtained prior to any study procedure.
Item
I certify that Informed Consent has been obtained prior to any study procedure.
date
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